Alerta De Seguridad para Commercial Name: Surgical Tables. Technical name: Surgical tables. ANVISA registration number: 80259110065. Risk class: I. Model affected: Mobile Surgical Tables. Affected serial numbers: All units manufactured since 2002 to date

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Maquet o Brasil Equipamentos Médicos Ltda; Maquet Gmbh.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    Since none of our devices can be definitively excluded from the possibility of being affected, we will perform the substruction. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 09/13/2016 - Date of notification notice to Anvisa: 03/16/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) ". #### UPDATED ON 09/05/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Causa
    As part of our after sales inspection services, a case has been reported in which a headrest was detached from the accessory adapter's docking profile (6005.25a0). upon investigation, it has been found that the feedstock of the accessory adapter (6005.25a0) does not conform to maquet specifications. the tensile and flexural strength of the material used is below that established for the specified materials. in addition, it has been identified that the accessory adapter (6005.25a0) has a specified weight of 11 kg at a distance of 300 mm, so it does not meet our stringent quality requirements. so far they have not been reported to customers in which someone has been injured.
  • Acción
    Field Action Code CAPA 2016-10 triggered under the responsibility of the company Maquet o Brasil Equipamentos Médicos Ltda. Will perform field correction.


  • Empresa matriz del fabricante (2017)
  • Source